Biofire Defense FilmArray NGDS Warrior Panel Recall: Outbreak Strain Mismatch Risk
Biofire Defense recalls FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 with UDI-DI code (01)00851458005136 due to potential outbreak strain mismatch. Affected units may not detect certain pathogens accurately.
Lower-risk recall
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.
What happened, in plain English
Biofire Defense is recalling a specific version of their FilmArray NGDS Warrior Panel diagnostic test because it may not match the outbreak strain used in real-world testing. This could lead to inaccurate results for detecting certain dangerous pathogens like anthrax and Ebola. Read more at govinfonow.com/recall/314271-biofire-defense-filmarray-ngds-warrior-panel-recall-outbreak-strain-mismatch.
Source Summary by GovInfoNow · govinfonow.com/recall/314271-biofire-defense-filmarray-ngds-warrior-panel-recall-outbreak-strain-mismatch · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2877-2026
Cite this page
“Biofire Defense FilmArray NGDS Warrior Panel Recall: Outbreak Strain Mismatch Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314271-biofire-defense-filmarray-ngds-warrior-panel-recall-outbreak-strain-mismatch. Based on FDA recall #Z-2877-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2877-2026%22&limit=1).
Why it’s dangerous
The test may not correctly identify certain pathogens in samples because the outbreak strain used in real-world testing doesn't match the reference strain used during development. This could lead to false negative results, meaning dangerous infections might go undetected.
Who’s affected
Laboratory users who purchased the FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 with UDI-DI code (01)00851458005136. Those testing for anthrax, plague, tularemia, Q fever, or Ebola/Marburg viruses are most at risk of inaccurate results.
How to tell if you have this one
Check for the product code REF NGDS-ASY-0007 and UDI-DI code (01)00851458005136 on the panel. Lot numbers 311825D, 312025D, 313526D, and 322925D are also affected.
- Brand
Biofire Defense- Product
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a- Category
Medical device
What to do — step by step
Check Product Details
Verify the product code REF NGDS-ASY-0007 and UDI-DI code (01)00851458005136 on the panel.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 21 states.
FDA distribution: “U.S. Nationwide distribution in the states of AL, CA, DC, FL, GA, HI, KY, LA, MA, MD, MN, NC, NH, NV, NY, OH, RI, TN, TX, UT, VA and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, District of Columbia, Florida, Georgia, Hawaii, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Nevada, New Hampshire, New York, North Carolina, Ohio, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington.
Recall timeline
FDA published this recall 27 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
What pathogens might this test miss?
The test may not detect Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, or Marburg virus accurately in some cases.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2877-2026 (July 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2877-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.